FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
6889–6912 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 16, 2008
NEURO III-SV
K083137 · LNH
Imris, Inc.
Radiology · 54d
Cleared Dec 16, 2008
PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
K083555 · LLZ
Emsoma Co., Ltd.
Radiology · 14d
Cleared Dec 15, 2008
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
K082224 · ITX
Shimadzu Medical Systems
Radiology · 131d
Cleared Dec 12, 2008
VISAGE PACS, VERSION 6.0/CS 3.1
K082269 · LLZ
Visage Imaging, Inc.
Radiology · 123d
Cleared Dec 12, 2008
IBA PROTON THERAPY SYSTEM- PROTEUS 235
K082416 · LHN
Ion Beam Applications S.A.
Radiology · 113d
Cleared Dec 12, 2008
MODEL TSX-301B AQUILION CT SYSTEM
K083282 · JAK
Toshiba America Medical Systems, In.C
Radiology · 35d
Cleared Dec 12, 2008
GE DISCOVERY NM/CT 570C
K083504 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 16d
Cleared Dec 12, 2008
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K083505 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 16d
Cleared Dec 05, 2008
HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
K081073 · OWB
Pausch, LLC
Radiology · 234d
Cleared Dec 05, 2008
MRI-PLAQUE VIEW, VERSION 1.1.2003
K082607 · LLZ
Vpdiagnostics, Inc.
Radiology · 88d
Cleared Dec 05, 2008
PRAGER SHELL
K082893 · ITX
Esi, Inc.
Radiology · 66d
Cleared Dec 05, 2008
KODAK 9500
K082972 · MUH
Trophy
Radiology · 60d
Cleared Dec 05, 2008
MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR
K083029 · IZW
Ralco S.R.L.
Radiology · 56d
Cleared Dec 05, 2008
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL...
K083086 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 50d
Cleared Dec 05, 2008
VIATRONIX V3D-CARDIAC, REVISION 1.0
K083293 · JAK
Viatronix, Inc.
Radiology · 25d
Cleared Dec 04, 2008
SUINSA DIAGNOSTIC X-RAY SYSTEM
K083109 · KPR
Suinsa
Radiology · 45d
Cleared Dec 01, 2008
VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600
K082456 · IYO
Verathon Incorporated
Radiology · 97d
Cleared Nov 26, 2008
QV-9000 UNIVERSAL SYSTEM
K083181 · KPR
Quantum Medical Imaging, LLC
Radiology · 29d
Cleared Nov 21, 2008
GE LUNAR FEMUR STRENGTH SOFTWARE
K072664 · KGI
Ge Medical Systems Ultrasound and...
Radiology · 428d
Cleared Nov 21, 2008
CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
K082432 · MWP
Bioptics, Inc.
Radiology · 91d
Cleared Nov 21, 2008
NORDICICE SOFTWARE
K082441 · LLZ
Nordicimaginglab AS
Radiology · 88d
Cleared Nov 21, 2008
SYMBIA, VERSION 4.0
K082506 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Nov 21, 2008
VIZTEK DR, MODELS: DR1000, DR3000, DR4000
K082604 · KPR
Viztek, Inc.
Radiology · 74d
Cleared Nov 21, 2008
NEORAY DR 2520 DIGITAL IMAGING SYSTEM
K083048 · IZL
Portavision Medical, LLC
Radiology · 38d